Intern - GRA bei Lilly

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The purpose of the Regulatory Delivery and Excellence (RD&E) Global Submission Publisher role is to:
• execute and maintain global regulatory submissions from candidate selection through end of product lifecycle.
• provide maintenance support as needed for submissions.
• coordinate the creation and legalization of regulatory submission documents supporting registration activities across the
international region
• meet customer requirements by optimizing business processes, tools and ensuring implementation of the regulatory
agency’s preferred electronic common technical document (eCTD) specifications in a quality way to promote timely
review by the regulatory agency.
• build eCTD and/or non-eCTD expertise and partner with Global Regulatory Associates, Regional Submission Associates,
Affiliate Regulatory, other publishing centers, vendors, and/or other contributing areas to align on submission specific
requirements and to ensure adherence to submission regulations and guidelines.

Execute submission workload
• Responsible for managing multiple submission types across assigned molecules.
o Coordinate and communicate with Global Regulatory Associates and Regional Submission Associates to
execute planned compliance and strategic submissions.
o Proactively manage 30-day packets to ensure compliance.
• Review and monitor RIM for delivery of planned documents in support of submissions and proactively update
document status to manage workload and provide information on specific documents’ status as it pertains to any
specific submission ensuring submissions are proactively processed such that they are delivered according to the
planned submission date.
• Escalate issues that may impact submissions and timelines.

Prepare Submission Cover letters and forms per appropriate regional submission and route for appropriate review
and approval.
• Plan submission workload by reviewing/monitoring RIM for planned documents for registration submissions.
• Partner with the Global Regulatory Associate and Regional Submission Associate to retrieve, publish, and submit
Modules 1-5 reports/documents and combine files into electronic submissions (eCTD) and/or non-eCTD
submissions according to the master table of contents or Content Plan for the dossier. Examples include:
o retrieve and publish CRFs and datasets required for regulatory submissions
o retrieve and publish literature references (bibliographies)
o retrieve, publish, and submit U.S. FDA required periodic reports
o retrieve, process, publish, and submit U.S. FDA required post-Marketing supplements and amendments
o ensure compliance with 30-Day Packet and Med Watch submissions.

publish different dossiers for Europe, the U.S., Canada, or other supported worldwide markets. Dossiers are
distributed to regulatory agencies and Lilly affiliate offices worldwide.
• Share knowledge, help train and educate others: about general submission knowledge including CRFs, datasets,
submission required literature references(bibliographies), periodic reports, post-Marketing supplements and
amendments.
• Coordinate global registration activities and provide the necessary documentation to affiliates for registration of
products in global countries. Duties include preparing and/or expertise in requesting Indiana Free Sale Certificates,
FDA Certificates of Pharmaceutical Product (CPPs), MOH GMP Certificates, Price Certificates, Regulatory Status
Letters, and Letters of Clarification.

Submit and archive submitted submissions, assuring all metadata fields are complete in RIM.
• Manage FDA Web trader account to enable submissions via electronic gateway.
• Assure all appropriate metadata fields are completed when archiving in electronic filing
system (RIM).
• Assure accurate entry for future retrieval of submissions if/when requested.

Computer Skills:
• Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness
• Experience with document management and Regulatory Information Management Systems (RIM)
• Broad technical knowledge (MS Word, Adobe Acrobat PDF Bookmarks and Hyperlinks, Acrobat Plug-ins, Document
Management Systems, Excel, ISI Toolbox, Lorenz)
• The individual must be able to maintain the security of confidential information

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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